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Recurring reports indicate that doctoral and postdoctoral students are regularly confronted with tasks that exceed contractually agreed duties and responsibilities. Research shows that such unreasonable tasks are dysfunctional to both the individual and the organization. However, there is a lack of reliable knowledge about more complex interconnections between unreasonable tasks and their consequences. The paper therefore investigates the mechanisms by which unreasonable tasks relate to doctoral and postdoctoral students' experience of their working conditions. The research model is tested using structural equation modelling (SEM) and data from 1053 doctoral and postdoctoral students at randomly selected German universities. The results reveal that unreasonable tasks have extensive and diverse negative effects on quantitative role overload, effort-reward imbalance, exhaustion, and intention to leave academia. In this way, the paper demonstrates how unreasonable tasks trigger sequences of negative effects that lead to the (post)doctoral students' intention to leave academia. The occurrence of unreasonable tasks is thus problematic not only for the individual, but also for the university as an organization.

The percentile distribution of blood pressure (BP) with regard to age, sex and cardiovascular risk factors is unknown. We aimed to provide epidemiological data for a comprehensive description of the BP distribution across a wide age-range. We used data from the German Metabolic and Cardiovascular Risk Project (GEMCAS), a cross-sectional study with 35 683 participants aged 18-99 years, conducted during October 2005 in 1511 randomly selected general practices in Germany. BP and waist circumference were measured, data on lifestyle, cardiovascular disease (CVD) risk factors and medication assessed. In men, we found even in the lowest percentile (5th) a gradual increase of the systolic BP from the lowest to the highest age group of 10 mm Hg, all other percentile groups an increase of 20 mm Hg. In women, this increase ranged from 15 mm Hg (5th percentile) to 40 mm Hg (95th percentile). In a subgroup of participants with no antihypertensive usage (n=22 550) and no CVD/CVD risk factors (n=13 297), we still observed a distinct age-related increase of BP readings. Our study provides detailed information on the population distribution of BP readings in both sexes and also among very old individuals. The results are useful in a public health context to plan gender- and age-specific prevention strategies. [ABSTRACT FROM AUTHOR]

BACKGROUND: In contrast to the well-documented high prevalence of overweight and obesity in the general population, the prevalence, recognition rates and management by primary care physicians-as the core gatekeeper in the health care system—remains poorly studied. PURPOSE OF THE STUDY: To examine (1) the point prevalence of overweight (BMI 25.0–29.9 kg/m2) and obesity (BMI ≥ 30kg/m2) in primary care patients, (2) prevalence patterns in patients with high-risk constellations (diabetes, hypertension, cardiovascular disease, etc.), (3) doctors' recognition and interventions, as well as patients' use and perceived effectiveness of weight-loss interventions and (4) factors associated with non-treatment. METHODS: Cross-sectional point prevalence study of 45 125 unselected consecutive primary care attendees recruited from a representative nationwide sample of 1912 primary care practices. Measures: (1) standardized clinical appraisal of each patient by the physician (diagnostic status and recognition, severity, comorbidity, current and past interventions). (2) Patient self-report questionnaire: height and weight, illness history, past and current treatments and their perceived effectiveness, health attitudes and behaviors. RESULTS: (1) In all, 37.9% of all primary care attendees were overweight, 1 9.4% obese. (2) Rates for overweight and obesity were highest in patients with diabetes (43.6 and 36.7%) and hypertension (46.1 and 31 .3%), followed by patients with cardiovascular disorders. Rates of overweight/obesity increased steadily by the number of comorbid conditions. (3) Doctors' recognition of overweight (20–30%) and obesity (50–65%) was low, patients' actual use of weight control interventions even lower (past 12 months: 8–11%, lifetime: 32–39%). Patient success rates were quite limited. (4) Co- and multimorbidity in particular as well as other patient and illness variables were identified as predictors for recognition, but prediction of patients' actual use of weight loss interventions was limited. CONCLUSIONS: Primary care management of overweight and obesity is largely deficient, predominantly due to four interrelated factors: doctors' poor recognition of patients' weight status, doctors' inefficient efforts at intervention, patients' poor acceptance of such interventions and dissatisfaction with existing life-style modification strategies. [ABSTRACT FROM AUTHOR]

Background: Arrhythmia recurrence after pulmonary vein isolation (PVI) is common. We conducted a multicenter, randomized trial to determine the impact of increased physical activity on atrial fibrillation recurrence after PVI., Methods: From 2018 to 2020, we randomly assigned 200 patients with atrial fibrillation to the ACTION or NO-ACTION group in 4 different centers in the local country of Brandenburg, Germany. Patients were eligible if they were scheduled to undergo PVI, aged ≥50 to ≤77 years, body mass index ≥23 to ≤35 kg/m 2 , and accepted wearing an activity tracker allowing 24-hour activity monitoring via mobile app. Patients in the ACTION group were actively remote-controlled via transmitted activity data by a physiotherapist, and individual motivational interviewing call sessions were scheduled with each ACTION patient every 2 weeks. The primary end point was the composite of recurrence of any atrial arrhythmia >30 seconds, additional ablation procedure, cardioversion, and new onset of antiarrhythmic drugs earliest after 90 days after index PVI over 12 months., Results: Overall, the median age of patients was 66 (interquartile range, 61-71) years, 33.5% were women, and 52% had persistent atrial fibrillation. The number of steps per day increased in both groups of patients from baseline to 12 months ( P <0.001). The absolute increase in steps per day did not differ between patients in the ACTION group with +3205 steps (597-4944) compared with those in the NO-ACTION group +2423 steps (17-4284), P =0.325. Unadjusted intention-to-treat analysis showed no difference in the primary composite end point in the ACTION group (27.3%) versus the NO-ACTION group (32.7%), P =0.405., Conclusions: Physical activity improved in patients after PVI. The present randomized controlled trial shows that activity tracker and motivational calls to increase physical activity versus activity tracker alone did not reduce the occurrence of the primary composite end point of atrial fibrillation recurrence or the absolute increase in steps per day., Registration: URL: https://www.cochranelibrary.com; Unique identifier: DRKS00012914., Competing Interests: None.

Background: The TIM-HF2 study demonstrated that remote patient management (RPM) in a well-defined heart failure (HF) population reduced the percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death during 1-year follow-up (hazard ratio 0.80) and all-cause mortality alone (HR 0.70). Higher rates of hospital admissions and mortality have been reported in HF patients with diabetes compared with HF patients without diabetes. Therefore, in a post-hoc analysis of the TIM-HF2 study, we investigated the efficacy of RPM in HF patients with diabetes., Methods: TIM-HF2 study was a randomized, controlled, unmasked (concealed randomization), multicentre trial, performed in Germany between August 2013 and May 2018. HF-Patients in NYHA class II/III who had a HF-related hospital admission within the previous 12 months, irrespective of left ventricular ejection fraction, and were randomized to usual care with or without added RPM and followed for 1 year. The primary endpoint was days lost due to unplanned cardiovascular hospitalization or due to death of any cause. This post-hoc analysis included 707 HF patients with diabetes., Results: In HF patients with diabetes, RPM reduced the percentage of days lost due to cardiovascular hospitalization or death compared with usual care (HR 0.66, 95% CI 0.48-0.90), and the rate of all-cause mortality alone (HR 0.52, 95% CI 0.32-0.85). RPM was also associated with an improvement in quality of life (mean difference in change in global score of Minnesota Living with Heart Failure Questionnaire score (MLHFQ): - 3.4, 95% CI - 6.2 to - 0.6)., Conclusion: These results support the use of RPM in HF patients with diabetes., Clinical Trial Registration: ClinicalTrials.gov NCT01878630., (© 2024. The Author(s).)

Background: Patients who experience an acute coronary syndrome (ACS) are at high risk of further cardiovascular events. Long-term treatment of cardiovascular risk factors, such as hyperlipidemia, is critical to prevent progression of coronary heart disease. However, many patients do not reach recommended target levels for low-density lipoprotein (LDL) cholesterol, despite receiving lipid-lowering therapy., Objective: To obtain an insight into the current treatment situation for very high-risk patients after an initial ACS in Germany., Methods: The multicenter HYDRA-ACS registry study was initiated to document the clinical characteristics of very high-risk patients with ACS and hyperlipidemia in clinical practice. In addition, lipid profiles, lipid-lowering therapy, and lipid target achievement during treatment were documented over 1 year., Results: 353 patients who were documented had a mean age of 57.3 years, mean body mass index was 28.6 kg/m 2 , and 73.4% were male; 52.4% had a family history of myocardial infarction (MI) and 32.6% a family history of coronary heart disease (CHD). Patients' medical histories commonly included CHD (32.9%), percutaneous coronary intervention (PCI; 25.5%), and previous ACS (23.0%). Common comorbidities included hypertension (68.6%), diabetes (17.3%), heart failure (16.7%), and stable angina pectoris (15.9%). The proportion of patients receiving lipid-lowering therapy increased from 65.7% at baseline to 100% at the 12-month follow-up (p < 0.0001). Substantial increases in use were seen for statins (85.0% vs. 36.5%, p = 0.0002) and cholesterol resorption inhibitors (32.9% vs. 8.6%, p = 0.0003). Use of combination therapy increased. The proportion of patients undertaking physical exercise increased (p < 0.0001), as did consumption of fruit and vegetables (p = 0.0222) and fish (p = 0.0162), while alcohol consumption decreased (p = 0.0019). Median LDL cholesterol level decreased significantly from baseline (87 vs. 166 mg/dL, p < 0.0001), and the proportion of patients with a level < 70 mg/dL increased (50.0% vs. 5.7%, p < 0.0001). Median HDL cholesterol increased (47 vs. 45 mg/dL, p = 0.0235) and median triglyceride level decreased (119 vs. 148 mg/dL, p = 0.0080). The proportion of patients receiving antihypertensive drugs and platelet aggregation inhibitors increased. The most frequent cardiovascular events during the 12-month follow-up were PCI (25.9%) and cardiac catheterization without PCI (12.9%); MI occurred in 2.4% of patients; no deaths were reported., Conclusions: This study provides a contemporary picture of the treatment of hyperlipidemia after ACS in patients in Germany. Despite treatment with lipid-lowering therapy, many patients did not achieve recommended lipid targets by 12 months after an ACS event., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: Type 2 diabetes causes cardio-renal complications and is treated with different combination therapies. The renal hemodynamics profile of such combination therapies has not been evaluated in detail., Methods: Patients (N = 97) with type 2 diabetes were randomized to receive either empagliflozin and linagliptin (E+L group) or metformin and insulin glargine (M+I group) for 3 months. Renal hemodynamics were assessed with para-aminohippuric acid and inulin for renal plasma flow (RPF) and glomerular filtration rate (GFR). Intraglomerular hemodynamics were calculated according the Gomez´ model., Results: Treatment with E+L reduced GFR (p = 0.003), but RPF remained unchanged (p = 0.536). In contrast, M+I not only reduced GFR (p = 0.001), but also resulted in a significant reduction of RPF (p < 0.001). Renal vascular resistance (RVR) decreased with E+L treatment (p = 0.001) but increased with M+I treatment (p = 0.001). The changes in RPF and RVR were different between the two groups (both p adjust  < 0.001). Analysis of intraglomerular hemodynamics revealed that E+L did not change resistance of afferent arteriole (R A ) (p = 0.116), but diminished resistance of efferent arterioles (R E ) (p = 0.001). In M+I group R A was increased (p = 0.006) and R E remained unchanged (p = 0.538). The effects on R A (p adjust  < 0.05) and on R E (p adjust  < 0.05) differed between the groups., Conclusions: In patients with type 2 diabetes and preserved renal function treatment with M+I resulted in reduction of renal perfusion and increase in vascular resistance, in contrast to treatment with E+I that preserved renal perfusion and reduced vascular resistance. Moreover, different underlying effects on the resistance vessels have been estimated according to the Gomez model, with M+I increasing R A and E+L predominantly decreasing R E , which is in contrast to the proposed sodium-glucose cotransporter 2 inhibitor effects., Trial Registration: The study was registered at www.clinicaltrials.gov (NCT02752113) on April 26, 2016., (© 2021. The Author(s).)

Background: Mitral valve (MV) surgery has traditionally been performed by conventional sternotomy (CS), but more recently minimally invasive surgery (MIS) has become another treatment option. The aim of this study is to compare short- and long-term results of MV surgery after CS and MIS., Methods: This study was a retrospective propensity-matched analysis of MV operations between January 2005 and December 2015., Results: Among 1357 patients, 496 underwent CS and 861 MIS. Matching resulted in 422 patients per group. The procedure time was longer with MIS than CS (192 vs. 185 min; p = 0.002) as was cardiopulmonary bypass time (133 vs. 101 min; p < 0.001) and X-clamp time (80 vs. 71 min; p < 0.001). 'Short-term' successful valve repair was higher with MIS (96.0% vs. 76.0%, p < 0.001). Length of hospital stay was shorter in MIS than CS patients (10 vs. 11 days; p = 0.001). There was no difference in the overall 30-day mortality rate. Cardiovascular death was lower after MIS (1.2%) compared with CS (3.8%; OR 0.30; 95%CI 0.11-0.84). The difference did not remain significant after adjustment for procedural differences (aOR 0.40; 95%CI 0.13-1.25). Pacemaker was required less often after MIS (3.3%) than CS (11.2%; aOR 0.31; 95%CI 0.16-0.61), and acute renal failure was less common (2.1% vs. 11.9%; aOR 0.22; 95%CI 0.10-0.48). There were no significant differences with respect to rates of stroke, myocardial infarction or repeat MV surgery. The 7-year survival rate was significantly better after MIS (88.5%) than CS (74.8%; aHR 0.44, 95%CI 0.31-0.64)., Conclusion: This study demonstrates that good results for MV surgery can be obtained with MIS, achieving a high MV repair rate, low peri-procedural morbidity and mortality, and improved long-term survival.

Introduction: Coronary artery disease (CAD) and peripheral arterial disease (PAD) account for significant morbidity and mortality in Germany and are more prevalent in rural, non-metropolitan areas. The goal of this study is to screen patients for their current atherosclerotic status, initiate treatment according to the latest scientific findings using a standardised multimodal approach and track their atherosclerotic status over one year., Methods and Analysis: This manuscript describes the study protocol of a prospective, multicentre registry of 500 sequential patients with CAD and/or PAD in rural, non-metropolitan regions of Germany. Patients, who visit the "WalkByLab" at the Brandenburg Medical School, Brandenburg, Germany, will be assessed by using our structured, multimodal risk factor management (SMART) tool to evaluate cardiovascular morbidity data, collect information on care and deliver multimodal therapy. The study's primary objective is a cross-sectional examination of the risk profile, diagnostic and therapeutic status in this patient group. Secondary objectives include the assessment of risk factor correlations as well as changes in risk-factor profile and therapy adherence. Patients will be examined at baseline and followed up at three-monthly intervals for one year. Over this time, atherosclerotic risk factors and patient adherence to defined therapeutic strategies will be evaluated. Study completion is estimated to be December 2021. An expansion of this concept into other rural, non-metropolitan neighbouring regions is planned., Ethics and Dissemination: This registry was assessed and approved by the ethics committee of the Brandenburg State Medical Association, Brandenburg, Germany, and conducted in accordance with the Declaration of Helsinki. The study findings will be disseminated through usual academic channels including meeting presentations and peer-reviewed publications., Protocol Version: 1.0., Competing Interests: The authors report no conflicts of interest in this work., (© 2021 Zemmrich et al.)

Background: Atherosclerotic cardiovascular disease is the leading cause of death and disability in the Western world., Objective: To characterise adults with confirmed coronary heart disease (CHD) and primary heterozygous familial or non-familial hypercholesterolaemia or mixed dyslipidaemia who received alirocumab in a real-world setting., Methods: This open, prospective, multicentre, non-interventional study, conducted in Germany, enroled patients with confirmed CHD who were treated with alirocumab according to its summary of product characteristics. Prescription was at the physician's discretion and independent of study participation. Patients were followed for 12 weeks after alirocumab initiation., Results: In total, 245 patients (mean age 62.2 years; 34.0% female) were documented at 90 sites. Overall, 47.7% had familial hypercholesterolaemia, 48.9% non-familial hypercholesterolaemia and 43.8% mixed dyslipidaemia; 74.6% had hypertension and 29.2% diabetes mellitus. The most common lipid-lowering therapy in the 12 months preceding alirocumab was a statin, often in combination with ezetimibe (73.5%). Statin contraindications were documented for 46.2% patients and statin intolerance for 63.8%. The mean low-density lipoprotein cholesterol (LDL-C)-level prior to alirocumab was 150.5±51.6 mg/dL. Alirocumab prescription was in compliance with German national recommendations and/or European guidelines. The most common starting dose was 75 mg every other week. Overall, 57% patients reached target LDL-C levels (<70 mg/dL) after 12 weeks of treatment. Alirocumab was generally well tolerated., Conclusion: In a real-world setting in Germany, alirocumab was prescribed for patients with atherosclerotic cardiovascular disease who had high baseline LDL-C levels with or without statin intolerance. Efficacy and safety were consistent with findings observed in the ODYSSEY Phase III programme., Competing Interests: Competing interests: PB and URK have received research support and/or consulting honoraria from Amgen, Merck and Sanofi. JM, CD and WDP are employees of and are holding stock in Sanofi. DS, CS and MK have no potential conflict of interest to disclose., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research., Methods: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation., Discussion: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses., Trial Registration: ClinicalTrials.gov identifier: NCT04053088 .

Objective: Treatment of peripheral artery disease (PAD), Fontaine Stage IIb with vasoactive substances is of limited efficacy and does not last beyond the active treatment. Glyceryl trinitrate (GTN) is a vasodilating agent that relaxes vascular smooth muscle cells. The aim was to prove the concept that GTN sublingual powder has sustained clinical efficacy and adequate safety in these patients., Methods: This was a multicentre, randomised, double blind, placebo controlled, forced titration, proof of concept study (phase IIa). Patients had a treadmill test at baseline, after 12 weeks of GTN/placebo administration, and at 19 and 26 weeks (without treatment). Primary objectives were an increase in initial claudication distance (ICD) and absolute claudication distance (ACD) at 12 weeks., Results: Ninety-five patients were screened and 73 randomised, of which 53 patients completed the 12 week treatment phase (GTN 26, placebo 27). At a baseline ICD of 59.2 ± 32.8 m (GTN) and 57.5 ± 39.7 m (placebo), GTN led to a placebo corrected ICD increase of 23.2% vs. baseline (p = .35). Baseline ACD was 105.3 ± 52.9 m (GTN) and 106.1 ± 95.0 m (placebo), and GTN led to a placebo corrected increase of 3.6% (p = .44), with substantial interindividual variation. The change in claudication distance was greater in patients with an ICD of ≥50 m at baseline (ΔICD 29.3%; p = .19), and an ACD ≥ 100 m (ΔACD 8.5%; p = .40). The effect lasted beyond the active treatment period as shown by a 49.3% increase in ICD (p = .31) and a 20.6% increase in ACD (p = .21) by week 26. GTN sublingual powder was well tolerated., Conclusion: Intermittent treatment with nitroglycerin sublingual powder may represent a potential treatment option for patients with PAD stage Fontaine IIb, with an immediate and a sustained effect. The observed increases in ACD and ICD were however not statistically significant in this phase IIa proof of concept study. Further studies are required., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Elevated pre-procedural high-sensitivity troponin T (hs-TnT) levels predict adverse outcomes in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). It is unknown whether elevated troponin levels still provide prognostic information during follow-up after successful TAVR. We evaluated the long-term implications of elevated hs-TnT levels found at 1-year post-TAVR., Methods and Results: The study included 349 patients who underwent TAVR for severe AS from 2010-2019 and for whom 1-year hs-TnT levels were available. Any required percutaneous coronary interventions were performed > 1 week before TAVR. The primary endpoint was survival time starting at 1-year post-TAVR. Optimal hs-TnT cutoff for stratifying risk, identified by ROC analysis, was 39.4 pg/mL. 292 patients had hs-TnT < 39.4 pg/mL (median 18.3 pg/mL) and 57 had hs-TnT ≥ 39.4 pg/mL (median 51.2 pg/mL). The high hs-TnT group had a higher median N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, greater left ventricular (LV) mass, higher prevalence of severe diastolic dysfunction, LV ejection fraction < 35%, severe renal dysfunction, and more men compared with the low hs-TnT group. All-cause mortality during follow-up after TAVR was significantly higher among patients who had hs-TnT ≥ 39.4 pg/mL compared with those who did not (mortality rate at 2 years post-TAVR: 12.3% vs. 4.1%, p = 0.010). Multivariate analysis identified 1-year hs-TnT ≥ 39.4 pg/mL (hazard ratio 2.93, 95% CI 1.91-4.49, p < 0.001), NT-proBNP level > 300 pg/mL, male sex, an eGFR < 60 mL/min/1.73 m 2 and chronic obstructive pulmonary disease as independent risk factors for long-term mortality after TAVR., Conclusions: Elevated hs-TnT concentrations at 1-year after TAVR were associated with a higher long-term mortality.

Objective: Functional tricuspid regurgitation (TR) is a frequent finding in echocardiography. Literature suggests significant TR is associated with poor prognosis. Still, data remain limited. This study aimed to evaluate long-term prognostic implications in patients with TR., Methods: In this observational cohort study, data from 1650 consecutive patients were analysed. Primary endpoint was all-cause mortality. Mean follow-up time was 1090 days. TR grades at baseline and follow-up were compared. Survival analyses were performed to identify prognostic factors., Results: At baseline, 14.1% patients showed no, 63.8% mild, 17.4% moderate and 4.7% severe TR. 359 patients (21.8%) died within the study period. TR at baseline was associated with excess mortality. Moderate and severe TR were of prognostic implication in all subgroups irrespective of systolic pulmonary artery pressure (sPAP) (

Background: Several observational studies have suggested a worrying reduction in hospitalisations for acute coronary syndromes in the emergency cardiology department in the last few months all over the world. The aim of the present study is to assess the impact of the current COVID-19 health crisis on admission for acute coronary syndrome (ACS) in the cardiology department of a tertiary general hospital in Germany with a COVID-19 ward., Methods and Results: The authors retrieved clinical data evaluating consecutive patients with ACS admitted to their emergency cardiology department. Data from January to June 2020, as well as for a 5-week period corresponding to this year's COVID-19 outbreak in south-west Germany (23rd March-26th April), were analysed and compared to data from equivalent weeks in the previous 2 years. A trend of reduction in admissions for ACS was observed from the beginning of the outbreak in the region at the end of March 2020. This trend continued and even intensified after a fall in COVID-19 cases in the area; the number of ACS patients in April 2020 was 25% and in June 29% lower than in January 2020 (p-value for linear trend <0.001). An even more consistent reduction was observed as compared with the equivalent weeks in the previous 2 years (38% and 30% lower than in 2019 and 2018, respectively; p = 0.009)., Conclusions: The COVID-19 health and social crisis has caused a worrying trend of reduced cardiological admissions for ACS, without evidence of a decrease in its incidence. Understanding and counteracting the causes appears to be crucial to avoiding major long-term consequences for healthcare systems worldwide.

Aims: Preserved vascular function represents a key prognostic factor in type 2 diabetes mellitus (T2DM), but data on vascular parameters in this patient cohort are scarce. Patients with T2DM often need more than one drug to achieve optimal glucose control. The aim of this study was to analyse the efficacy of two combination therapies on vascular function in subjects with T2DM., Methods and Results: This prospective, randomized study included 97 subjects with T2DM. Subjects were randomized to either the combination therapy empagliflozin (E) 10 mg with linagliptin (L) 5 mg once daily or metformin (M) 850 or 1000 mg twice daily with insulin glargine (I) once daily. At baseline and after 12 weeks, subjects had peripheral office and 24-h ambulatory blood pressure (BP) measurement and underwent vascular assessment by pulse wave analysis under office and ambulatory conditions. Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I. There were greater decreases in 24-h ambulatory peripheral systolic (between-group difference: -5.2 ± 1.5 mmHg, P = 0.004), diastolic BP (-1.9 ± 1.0 mmHg, P = 0.036), and PP (-3.3 ± 1.0 mmHg, P = 0.007) in E + L than M + I. Central office systolic BP (-5.56 ± 1.9 mmHg, P = 0.009), forward pressure height of the pulse wave (-2.0 ± 0.9 mmHg, P = 0.028), 24-h ambulatory central systolic (-3.6 ± 1.4 mmHg, P = 0.045), diastolic BP (-1.95 ± 1.1 mmHg, P = 0.041), and 24-h pulse wave velocity (-0.14 ± 0.05m/s, P = 0.043) were reduced to a greater extent with E + L., Conclusion: Beyond the effects on glycaemic control, the combination therapy of E + L significantly improved central BP and vascular function compared with the classic combination of M + I., Clinicaltrials.gov: NCT02752113., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: We aimed to find out how the concomitant performance of tricuspid valve repair (TVR) affects outcomes of patients undergoing mitral valve surgery (MVS)., Methods: Single-centre, retrospective analysis of 1357 patients who underwent MVS between January 2005 and December 2015, including 1165 patients with isolated MVS and 192 patients with MVS plus TVR. We used propensity scores to match patients for baseline characteristics other than valve related parameters and arrived at a matched sample of 182 patients per group., Results: The overall procedure duration was longer in the MVS + TVR (224 min) versus the MVS group (176 min; p < 0.001), as were the duration of mechanical ventilation (13 vs. 11 h; p < 0.001), X-clamp (90.5 vs. 66 min; p < 0.001) and cardiopulmonary bypass time (136 vs. 95.5 min; p < 0.001). Rates of procedural complications were not different between groups with the exception of pacemaker rates which were 16.0% in the MVS + TVR group and 8.8% in the isolated MVS group (p = 0.037). There was no difference in death rates within 30 days, stroke, myocardial infarction or repeat MVS. The long-term survival rate was 60.8% in the MVS + TVR vs. 57.5% in the isolated MVS group (HR 1.048; 95%CI 0.737-1.492; p = 0.794). The rate of grade III/IV tricuspid regurgitation (TR) remained low after MVS + TVR during long-term follow-up while the rate of grade ≥ II TR increased slightly in the isolated MVS group., Conclusion: The data show that the concomitant performance of TVR in patients undergoing MVS is a safe and effective procedure with good long-term outcomes. Patients can undergo MVS + TVR with confidence as it improves their prognosis up to the level of patients undergoing isolated MVS.

Background: To analyze key indicators of metabolic control in adults with type 1 diabetes (T1D) using real-time or intermittent scanning continuous glucose monitoring (rtCGM/iscCGM) during real-life care, based on the German/Austrian/Swiss Prospective Diabetes Follow-up (DPV) registry. Methods: Cross-sectional analysis including 233 adults with T1D using CGM. We assessed CGM metrics by gender, age group (18 to <30 years vs. ≥30 years), insulin delivery method (multiple daily injections vs. continuous subcutaneous insulin infusion [CSII]) and sensor type (iscCGM vs. rtCGM), working days versus weekends, and daytime versus night-time using multivariable linear regression models (adjusted for demographic variables) or Wilcoxon signed-rank test. Results: Overall, 79/21% of T1D patients used iscCGM/rtCGM. Those aged ≥30 years spent more time in range (TIR [70-180 mg/dL] 54% vs. 49%) and hypoglycemic range <70 mg/dL (7% vs. 5%), less time in hyperglycemic range >180 mg/dL (38% vs. 46%) and had a lower glucose variability (coefficient of variation [CV] 36% vs. 37%) compared with adults aged <30 years. We found no significant differences between genders. Multivariable regression models revealed the highest Time In Range (TIR) and lowest time with sensor glucose >250 mg/dL, CV and daytime-night-time differences in those treated with CSII and rtCGM. Glucose profiles were slightly more favorable on working days. Conclusions: In our real-world data, rtCGM versus iscCGM was associated with a higher percentage of TIR and improved metabolic stability. Differences in ambulatory glucose profiles on working and weekend days may indicate lifestyle habits affecting glycemic stability. Real-life CGM results should be included in benchmarking reports in addition to hemoglobin A1c (HbA1c) and history of hypoglycemia.

Introduction: Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin., Research Design and Methods: Data from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014-2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected., Results: Over time, the proportion of recipients aged <65 years decreased (71.1% vs 54.4% among early and late adopters), male patients increased (from 50.9% to 66.5%), body mass index (mean±SD) decreased (from 35.5±6.7 to 32.7±6.6 kg/m 2 ), proportion with cardiovascular morbidities increased (from 20.4% to 26.4%), and mean estimated glomerular filtration rate decreased (from 83.2±19.5 to 78.5±21.1 mL/min/1.73 m 2 ) (all p<0.001). Patients increasingly received empagliflozin in combination with metformin (60.8% vs 68.6% of early and late adopters; p<0.001), glucagon-like peptide-1 (GLP-1) agonists (11.0 vs 14.1%; p<0.001) or insulin (34.3% vs 49.9%; p<0.001). Empagliflozin was generally added to existing antidiabetic regimens. Six months after empagliflozin initiation, the mean glycated hemoglobin (HbA1c) decreased by 0.4%, the proportion of patients with HbA1c <6.5% increased (19.2% vs 12.8%), and the mean fasting plasma glucose decreased (155.8±49.7 vs 168.0±55.1 mg/dL) (all p<0.001). No significant changes in rates of severe hypoglycemia and no cases of diabetic ketoacidosis were seen., Conclusions: Over time, empagliflozin is being prescribed to a broader patient range in routine practice, is usually added to existing antidiabetic regimens, and is increasingly used in combination with metformin, GLP-1 agonists and/or insulin. Empagliflozin had a beneficial effect on glycemic control, with no increase in hypoglycemia., Competing Interests: Competing interests: JS and TD report grants and personal fees from Abbott, AstraZeneca, and Sanofi, outside the submitted work. PB reports to have received research support from the funders of DIVE. MG, JF and LL are employees of Boehringer Ingelheim. SRT, CW, KK, DR, RW-L, DE, and JH have no competing interests to disclose., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

This study aimed to investigate the rate of severe structural valve deterioration (SVD) and long-term outcomes of patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Propensity score matched analysis of patients who underwent TAVI (n = 216) and SAVR (n = 216) between 2008 and 2012. Long-term echocardiographic parameters and clinical outcomes were assessed after more than 6 years after TAVI/SAVR. Rate of severe SVD was 10.5% versus 4.5% in the TAVI and SAVR groups, respectively, but the difference was not statistically significant (hazard ratio [HR] 2.5; 95% confidence interval [CI] 0.7 to 8.3; p = 0.159). This was largely driven by higher rates of mean transprosthetic gradient ≥40 mm Hg (7.0 vs 3.4%; p = 0.327) and aortic regurgitation (4.7% vs 0%; p = 0.058). TAVI patients had lower survival rates at 6 years than SAVR patients (40.7% vs 59.6%, respectively, p <0.001, HR 2.15; 95% CI 1.45 to 3.20). Rate of cardiovascular events (14.4% TAVI vs 18.2% SAVR, HR 0.8; 95% CI 0.4 to 1.3; p = 0.347) and permanent pacemaker implantation (PPI; 16.0% TAVI vs 9.2% SAVR, p = 0.234) was similar between the 2 groups. In conclusion, incidence of moderate and severe SVD was not statistically different between TAVI and SAVR. Rate of moderate or severe aortic regurgitation was significantly higher in the TAVI group with predominant use of first-generation valves. Reintervention rate was low in both groups. Survival rate was lower after TAVI, probably because of higher frailty index, but incidence of cardiovascular events, PPI, and SVD was similar in both groups., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: A logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) ≥20% is frequently recognised as a finite criteria for transcatheter aortic valve implantation (TAVI) reimbursement, despite guideline modifications to reflect the appropriacy of TAVI in selected lower-risk patients. The aim was to evaluate the clinical value of this threshold cut-off in TAVI patients and to identify factors associated with mortality in those below this threshold., Methods: We analysed data from a single-centre, German, observational, TAVI-patient registry, gathered between 2008 and 2016. Patients were stratified by logEuroSCORE (≥ or <20%) for comparisons. Logistic regression was performed to identify predictors of mortality at 1 year, with this analysis used to generate a calculated ('real') risk value for each patient., Results: 1679 patients (logEuroSCORE <20%: n=789; logEuroSCORE ≥20%: n=890) were included. LogEuroSCORE <20% patients were significantly younger (80.1 vs 81.6 years; p<0.001) and less comorbid than logEuroSCORE ≥20% patients, with a higher rate of transfemoral TAVI (35.6% vs 26.1%; p<0.001) and predilation (70.0% vs 63.3%; p=0.004). Patients with a logEuroSCORE <20% experienced more vascular complications (3.4% vs 1.5%; p=0.010). One-year survival was 88.3% in the logEuroSCORE <20% and 81.8% in the logEuroSCORE ≥20% group (p=0.005), with the calculated mortality risk falling within 2% of the logEuroSCORE in just 12.9% of patients. In the logEuroSCORE <20% group, only coronary artery disease was significantly predictive of 1-year mortality (OR 2.408; 95% CI 1.361 to 4.262; p=0.003)., Conclusions: At our institution, patients with a logEuroSCORE <20% selected for TAVI have excellent outcomes. The decision not to reimburse TAVI in such patients may be viewed as inappropriate., Competing Interests: Competing interests: PB is a consultant for Edwards Lifesciences., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: Our study aimed to analyse treatment strategies after failure of initial metformin mono-therapy in adult patients with type-2 diabetes (T2DM)., Methods: The DIVE and DPV databases were combined and 16,681 adult patients with T2DM and metformin mono-therapy identified. Patients were analysed depending on whether metformin was continued (MET), or whether it was combined with other oral antidiabetics (OAD), with GLP-1 antagonists (GLP-1) or with basal insulin (BOT/BOT plus). Metabolic control, body weight and hypoglycaemia, micro- and macro-vascular events were compared within 1 year., Results: A total of 11,911 (71%) participants continued MET until the end of the observation period, 3334 (20.0%) were intensified using OAD, 579 (3%) started on GLP-1, and 857 (5%) were initiated on BOT/BOTplus. Predictors of OAD and BOT/BOTplus therapy were elevated HbA1c, longer diabetes duration and the presence of micro- and macro-vascular diseases, while GLP-1 therapy was predicted by younger age, female sex, higher body weight and shorter diabetes duration. Micro- and macro-vascular diseases were negative predictors of GLP-1 therapy. Effects on HbA1c were highest in the BOT/BOTplus and OAD group, while GLP-1 treatment had the best effect on body weight., Conclusions: BOT/BOTplus and OAD show good HbA1c reduction even in patients with longer diabetes duration and in older patients. GLP-1 therapy is effective concerning weight loss in overweight patients and is more often used in females and patients with shorter diabetes duration. Interestingly, despite several studies showing positive effects on micro- and macro-vascular outcomes, prevalent macro-vascular diseases are no predictors of GLP-1 use.

Background: Hypertension is poorly controlled in numerous patients despite effective medication being available. Catheter-based renal denervation (RDN) has emerged as an alternative treatment option. We aimed to assess how likely patients with elevated blood pressure (BP) are to accept RDN as treatment option., Methods: A questionnaire-based cross-sectional survey was performed in patients with elevated BP in Germany. Data on patient demographics, clinical characteristics and treatment preferences were collected, anonymized and analyzed., Results: One thousand and eleven patients completed the survey. Mean age was 66 years (55% male). If not already on medication (n = 172), 38.2% of patients would prefer RDN. Of those already on drug therapy (n = 839), 28.2% would opt for RDN. Patients who were pro-RDN were younger (p < 0.0001) and more often male (p < 0.0001). Nineteen percent would choose RDN if it lowered systolic BP by at least 20 mmHg, more than 40% if they did not have to take any more pills thereafter, and 30% if it would lower BP by at least 10 mmHg. Experiences of side effects and drug adherence were identified as determinants of patient preference. Physicians were the main source of information regarding medical problems (95.5%) and influence patients' decision regarding therapies (98%)., Conclusions: This survey found that a significant proportion of patients would choose catheter-based RDN over lifelong pharmacotherapy. These patients were younger and more likely to be male but their expectation of the extent of BP decrease with RDN was high. Physicians are key mediators for treatment selection. They need to incorporate patient preferences into shared decision making.

Introduction: Insulin glargine 300 U/ml (U300) was registered based on the EDITION clinical trial program. The aim of this database analysis was to describe the profile of adult U300 recipients with type-1 (T1DM) or type-2 diabetes (T2DM)., Methods: The analysis was based on data from the German DIVE/DPV registries. Patients were sampled in May (DIVE) and in March 2018 (DPV) and divided into those who commenced U300 within the 1st year (early adopters) or 2nd year (late adopters). Patients were further compared to patients receiving U100 during the same time period., Results: Among 581,519 adult patients contained in the databases, 7268 with either T1 or T2DM received U300 and 22,050 U100. Baseline characteristics of U300 and U100 recipients did not differ substantially in both types of diabetes. Patients with T2DM had many risk factors and comorbidities. The median HbA1c (both T1DM and T2DM, 8.1% for U300 and 7.9 and 8.3% for U100) and fasting blood glucose values were similar at baseline. Severe hypoglycemia was less prevalent in T2DM and among recipients of U300 (3.1 vs. 3.9%), whereas in T1DM the rate was higher (10.6 vs. 10.1%). There were minor, but clinically probably irrelevant, differences in age and BMI for T1DM and T2DM between the first and second years. Patients with T2DM being initiated in the second year had a higher HbA1c value (8.6 vs. 8.3%) than those initiated during the first year. Patients in clinical practice showed substantially higher HbA1c values in both T1DM and T2DM, and doses used were lower than those reported from the EDITION trial program. U300 patients had a longer diabetes duration (T1 and T2DM), a higher BMI and received higher basal insulin doses (T1 and T2DM) compared to U100. While HbA1c was comparable, the rate of severe hypoglycemia under U300 was reduced in T2DM but not T1DM with or without adjustment for differences in baseline characteristics in T2DM., Conclusion: The data confirm the clinical profile documented for U300 in the EDITION studies during the first years of its registration. In an unselected patient population, there was a lesser rate of severe hypoglycemia but at a comparable HbA1c., Funding: German Centre for Diabetes Research (DZD) (01GI1106), the European Foundation for the Study of Diabetes (EFSD) and the German Diabetes Society (DDG). The DIVE registry (organized as Diabetes Agenda 2010 GmbH, Berlin, Germany) received funding from Sanofi, AstraZeneca, Bayer, and Abbott and was conducted under the auspices of diabetesDE.

Background: This study compared long-term outcomes of biological and mechanical mitral valve replacement (MVR) in patients requiring replacement of the mitral valve where repair was not feasible., Methods: A single-centre registry of patients receiving MVR between 2005 and 2015 was established. Thirty-day mortality and long-term outcomes were analysed and compared., Results: Three hundred twenty four patients underwent MVR (265 biological; 59 mechanical valves). Patients receiving biological valves were older (p < 0.001), had a higher log EuroSCORE (p < 0.001) and received less minimally invasive surgery (p < 0.001). Immediate procedural mortality was 1.9%, which only occurred in the biological valve group. At 30 days, 9.0% of patients had died, 4.0% experienced stroke, 8.0% received a pacemaker and 10.5% suffered an acute renal failure. The rate of re-thoracotomy (14.2%) was lower in the biological (12.5%) than in the mechanical valve group (22.0%; adjOR 0.45 [0.20-1.00]; p = 0.050). Frequent long-term complications were stroke (9.2%) and bleeding (4.8%), with bleeding complications being higher in the mechanical valve group (p = 0.009). During the follow-up period biological valves showed a numerically higher survival rate during the first years, which shifted after 3 years in favour of mechanical valves. At 10 years, survival rates were 62.4% vs. 77.1% in the biological and mechanical valve groups (p = 0.769). Hazard ratio after adjustment was 0.833 (95% CI 0.430-1.615)., Conclusion: These data confirm that mechanical valve implantation is associated with an increased risk of bleeding. While there was a potential survival benefit during the first years after surgery for patients receiving a biological valves the difference became insignificant after a follow-up of 10 years.

Background: Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI., Methods: This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276)., Results: There was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 [95% confidence interval (CI) 0.64-1.91]) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11-4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18-1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97-1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98-1.49; p = 0.079) after multivariable adjustment., Conclusions: Although insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.

Background: To evaluate the characteristics of type 2 diabetes (T2DM) patients with or without chronic kidney disease (CKD) in Germany., Methods: Using combined DPV/DIVE registry data, the analysis included patients with T2DM at least ≥ 18 years old who had an estimated glomerular filtration rate (eGFR) value available. CKD was defined as an eGFR < 60 mL/min/1.73 m 2 or eGFR ≥ 60 mL/min/1.73 m 2 and albuminuria (≥ 30 mg/g). Median values of the most recent treatment year per patient are reported., Results: Among 343,675 patients with T2DM 171,930 had CKD. Patients with CKD had a median eGFR of 48.9 mL/min/1.73 m 2 and 51.2% had a urinary albumin level ≥ 30 mg/g. They were older, had a longer diabetes duration and a higher proportion was females compared to patients without CKD (all p < 0.001). More than half of CKD patients (53.5%) were receiving long-acting insulin-based therapy versus around 39.1% of those without (p < 0.001). CKD patients also had a higher rate of hypertension (79.4% vs 72.0%; p < 0.001). The most common antihypertensive drugs among CKD patients were renin-angiotensin-aldosteron system inhibitors (angiotensin converting enzyme inhibitors 33.8%, angiotensin receptor blockers 14.2%) and diuretics (40.2%). CKD patients had a higher rate of dyslipidemia (88.4% vs 86.3%) with higher triglyceride levels (157.9 vs 151.0 mg/dL) and lower HDL-C levels (men: 40.0 vs 42.0 mg/dL; women: 46.4 vs 50.0 mg/dL) (all p < 0.001) and a higher rate of hyperkalemia (> 5.5 mmol/L: 3.7% vs. 1.0%). Comorbidities were more common among CKD patients (p < 0.001)., Conclusion: The results illustrate the prevalence and morbidity burden associated with diabetic kidney disease in patients with T2DM in Germany. The data call for more attention to the presence of chronic kidney disease in patients with diabetes, should trigger intensified risk factor control up and beyond the control of blood glucose and HbA1c in these patients. They may also serve as a trigger for future investigations into this patient population asking for new treatment options to be developed.

Background: Transcatheter aortic valve implantation (TAVI) is a standard therapy for aortic valve stenosis in patients at intermediate-to-high surgical risk. Previously, TAVI at our site was performed by a minimalist heart team (MHT), comprised of two interventional cardiologists, echocardiography staff and two cardiac catheterization laboratory nurses. After revision of German Federal Joint Committee (G-BA) guidelines in September 2015, the presence of an extended heart team (EHT; including a full cardiac surgical team) became mandatory throughout the TAVI procedure. We aimed to evaluate the impact of the EHT on clinical and economical outcomes., Methods: Data was retrospectively extracted from the medical records of patients receiving an Edwards SAPIEN 3 valve at the University Hospital Tübingen, Germany, between 2014 and 2017 and matched with cost data from the national invoice system of hospitals (InEK). For comparison, patients were grouped according to whether they underwent TAVI with or without the EHT., Results: Overall, data for 341 patients (MHT 233; EHT 118) were analysed. Baseline characteristics were largely similar between groups (mean age 81.0 years; 54.5% female), though EHT patients had a lower mean logEuroSCORE (17.5% vs. 19.8%; p = 0.011) and more prior PCI/stenting (39.0% vs. 26.9%; p = 0.022). The rate of immediate procedural death (1.7%) was comparable between groups, as was mortality at 30 days (4.2%). Overall, 1.2% of patients required conversion to surgery. The cost of the index hospitalisation (minus the prosthesis) was higher in the EHT condition (difference + €1604), largely driven by expenditure on physicians (difference + €581; p < 0.001), medical technicians (difference + €372; p < 0.001) and medical supplies (difference +€244; p = 0.001)., Conclusion: At our site, the presence of an EHT throughout the TAVI procedure appears to substantially increase hospital expenditure without significantly improving patient outcomes. We suggest that TAVI by a minimalist HT with a surgical team on call in case of emergency may be sufficient.

End-stage renal disease (ESRD) affects approximately 2% to 4% of patients with severe aortic stenosis. It is because these patients have been excluded from clinical trials, the impact of transcatheter aortic valve implantation (TAVI) in this patient group has not been thoroughly investigated. Between April 2008 and March 2015, 2,000 patients (dialysis group, n = 56 [2.8%]) were consecutively enrolled when diagnosed with severe aortic stenosis and eligible to undergo TAVI. Procedural and longer-term outcomes were analyzed and adjusted for differences in baseline characteristics. Patients on dialysis had a higher periprocedural mortality (10.7% vs 1.7%; adjusted odds ratio [adjOR] 5.65, 95% confidence interval [CI] 1.91 to 16.67; p = 0.002) and a lower Valve Academic Research Consortium (VARC)-II (VARC) defined device success (adjOR 0.34, 95% CI 0.15 to 0.79; p = 0.012). At 30 days, there was an increased rate of all-cause mortality (21.4 vs 4.8%; adjOR 4.90, 95% CI 1.96 to 12.26; p = 0.001), cardiovascular (adjOR 3.67, 95% CI 1.43 to 9.41; p = 0.007) and noncardiovascular mortality (adjOR 6.28, 95% CI 1.36 to 9.41; p = 0.019), myocardial infarction (adjOR 9.39, 95% CI 1.84 to 48.03; p = 0.007), bleeding (adjOR 2.48, 95% CI 1.06 to 5.83; p = 0.036) as well as the VARC-II defined early safety combined end point (adjOR 2.97, 95% CI 1.28 to 6.90; p = 0.012) associated with dialysis. Dialysis was associated with poor survival at one (57.1% vs 84.2%) and 3 years (26.8% vs 66.9%) with or without the consideration of the first 72 hours (p <0.001; adjusted p <0.001). Although, in the multivariable regression analysis, reduced ejection fraction, peripheral arterial disease, pulmonary hypertension (PH), frailty and dialysis were associated with 1-year mortality, only PH (>60 mm Hg) remained significant in an analysis restricted to the dialysis patients (adjusted hazard ratio 2.68; 95% CI 1.18 to 5.88; p = 0.018). PH had a sensitivity of 45.8%, a specificity of 81.3%, and a positive predictive value of 64.7%. In conclusion, dialysis is an independent predictor of mortality in patients who underwent TAVI. Long-term mortality in dialysis patients appears to be largely determined by the kidney disease and/or dialysis itself whereas VARC-II defined complications are largely unaffected. An increased short-term mortality still calls for (pre-) procedural optimization., (Copyright © 2018. Published by Elsevier Inc.)

Background: Glargine U300 (Gla-300) is a further development of glargine U100 (Gla-100). Since 2015, Gla-300 has been available in Germany and Austria. We compared patients initiating therapy with Gla-300 with patients starting with Gla-100. Moreover, it was investigated whether patients from real-life diabetes care differ from patients participating in the EDITION clinical study program., Methods: Data are based on the diabetes registries DPV and DIVE. Patients started/switched to Gla-100 or Gla-300 in 2015 were included. Linear regression was applied for bodyweight (BW), BMI, HbA 1C , daily total and basal insulin dose/kgBW and negative binomial regression for severe hypoglycemia. Data were adjusted for age, sex, and diabetes duration., Results: 14,123 patients were identified (Gla-100: 11,397; Gla-300: 2726). Gla-300 patients with T1D were older, T2D patients younger compared to subjects using Gla-100 (both p < 0.0001). In Gla-300 subjects, diabetes duration was longer (both p < 0.0001). Patients started/switched to Gla-300 had a higher BW, a higher BMI and a lower baseline HbA 1C . The rate of severe hypoglycemia was comparable. Total and basal insulin doses/kgBW were higher in patients with Gla-300. DPV/DIVE subjects were older, had a lower BW, and were more frequently male compared to EDITION patients. HbA 1C was higher in T1D patients from DPV/DIVE., Conclusion: Data from the diabetes registries DPV/DIVE indicate differences between Gla-300 and Gla-100 patients at the onset of insulin therapy. This analysis provides additional information to the EDITION clinical study program.

Aims: On the basis of the Diabetes Versorgungs-Evaluation (DIVE) and Diabetes-Patienten-Verlaufsdokumentation (DPV) datasets, we aimed to explore the impact of differences in treatment modalities on outcomes in Germany and put these into a global context., Methods: The 2014 to 2016 DIVE and DPV databases were combined, and a total of 127 838 patients 18 years and older was analysed with respect to demographics, cardiovascular risk factors, comorbidities, treatments, and outcomes, separately for each German state. Estimates were expressed as adjusted least squares means together with 95% confidence intervals., Results: Saarland dataset recorded the lowest mean HbA 1c (6.7%; 6.6%-6.8%; 50 mmol/mol, 49-51 mmol/mol), Saxony-Anhalt showed the highest (8.3%; 8.2%-8.3%; 67 mmol/mol, 66-67 mmol/mol). The highest percentage of hypoglycaemic events was reported in Mecklenburg-West Pomerania (MWP) (4.7%; 3.9%-5.7%), the lowest in Thuringia (0.9%; 0.2%-3.4%). Metformin and sulfonylurea accounted for 36.4% to 53.3% of anti-diabetic treatments across states; other antihyperglycaemic drugs such as DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 analogues were used most often in MWP (40.0%; 37.8%-42.1%) and least in Rhineland-Palatinate (13.6%; 13.0%-14.2%). Treatment with insulin (alone or in combination) was reported most often in MWP (78.2%; 76.4%-80.0%) and least in Thuringia (26.0%; 20.1%-32.9%)., Conclusions: Federal states in Germany are heterogeneous concerning diabetes treatment and associated outcomes. These data should stimulate further discussion about how optimal diabetes care can be implemented in all areas of Germany, to achieve good treatment outcomes in all federal states., (© 2018 John Wiley & Sons, Ltd.)

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented. Data for 225 patients (TAVI 132, SAVR 93) aged ≥75 and <86 years and fulfilling minimal-risk criteria were analyzed. Patients who underwent TAVI were older (80.7 vs 77.4 years, p <0.0001) and had a higher mean Society of Thoracic Surgeons score (2.16% vs 1.72%, p <0.0001). Mild prosthetic valve regurgitation (odds ratio [OR] 4.9, 95% confidence interval [CI] 3.34 to 7.20) was more likely after TAVI, as were renal complications (predominantly stage I acute kidney injury; OR 2.86, 95% CI 1.79 to 4.55) and new pacemaker implantation (OR 3.33, 95% CI 1.76 to 6.26) at 30 days; however, life-threatening bleeding (OR 0.58, 95% CI 0.36 to 0.93) and reintervention for bleeding (OR 0.03, 95% CI 0.01 to 0.13) were less likely. Survival was comparable between groups at 30 days (99.2% vs 100%, p = 1.0) and 1 year (96.2% vs 96.8%, OR 0.85, 95% CI 0.20 to 3.63, p = 0.823), but it was poorer for patients who underwent TAVI at 2 years (OR 0.31, 95% CI 0.16 to 0.61). In conclusion, the short-term outcomes of TAVI in elderly, low-risk, minimally co-morbid patients appear to be similar to those of SAVR, with access-specific complications. Although these results point toward the potential for more liberal use of TAVI in minimal-risk patients, poorer midterm survival remains a concern, requiring further exploration., (Copyright © 2018. Published by Elsevier Inc.)

Background: In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes., Methods: InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only., Results: Two hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients., Conclusion: In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage., Trial Registration: clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

Background: There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding and thromboembolic complications., Methods: We conducted a single-centre study in patients undergoing left atrial ablation of AF. Three groups were defined: 1) bridging: interrupted vitamin-K-antagonists (VKA), INR ≤2, and bridging with heparin; 2) VKA: uninterrupted VKA and INR of > 2; 3) DOAC: uninterrupted direct oral anticoagulants. Bleeding complications, thromboembolic events and peri-procedural heparin doses were assessed., Results: In total, 780 patients were documented. At 48 h, major complications were more common in the bridging group compared to uninterrupted VKA and DOAC groups (OR: 3.42, 95% CI: 1.29-9.10 and OR: 3.01, 95% CI: 1.19-7.61), largely driven by differences in major pericardial effusion (OR: 4.86, 95% CI: 1.56-15.99 and OR: 4.466, 95% CI, 1.52-13.67) and major vascular events (OR: 2.92, 95% CI: 0.58-14.67 and OR: 9.72, 95% CI: 1.00-94.43). Uninterrupted VKAs and DOACs resulted in similar odds of major complications (overall OR: 1.14, 95% CI: 0.44-2.92), including cerebrovascular events (OR: 1.21, 95% CI: 0.27-5.45). However, whereas only TIAs were observed in DOAC and bridging groups, strokes also occurred in the VKA group. Rates of minor complications (pericardial effusion, vascular complications, gastrointestinal hemorrhage) and major/minor groin hemorrhage were similar across groups., Conclusion: Our dataset illustrates that uninterrupted VKA and DOAC have a better risk-benefit profile than VKA bridging. Bridging was associated with a 4.5× increased risk of complications and should be avoided, if possible.

Background: Chronic ischemic heart disease take the first place in cause of death in Germany. The proportion of patients aged 75 years or older amounts more than 80 %. Due to their growing part of population the medical care of older patients becomes increasingly important. In this investigation patients aged ≥ 75 years with coronary three-vessel disease were characterized and various treatment strategies were compared., Patients and Methods: This analysis was retrospective. The data of patients aged 75 years or older with three-vessel disease diagnosed by coronary angiography at the Klinikum Lippe Detmold between 2005 and 2007 were collected. Depending on the received therapy they were parted in three groups: optimal drug therapy (OMT), interventional - (PCI) and surgical revascularization (CABG). Patient characteristics as well as survival- and MACCE-rates during follow up were ascertained. Subgroup analyzes were performed for acute coronary syndrom (ACS) and stable coronary artery disease( CAD)., Results: The data of 434 patients with an average age of 79 years were documented. 139 (32.0 %) were assigned to the OMT- 189 (43.6 %) to the PCI- and 106 (24.4 %) to the CABG-group. Overall there was no significant difference between the three groups regarding mortality. In the subgroup of patients wit ACS (n = 180) mortality significantly increased in the OMT-group compared to the two invasive therapies (PCI (p = 0.029), CABG (p = 0.045)). The subgroup of patients with stable CAD showed no significant differences in mortality between the three types of therapy., Conclusions: Older patients benefit from an interventional or surgical revascularization in the context of ACS. In contrast, in elderly with stable CAD optimal medical therapy provides a reasonable alternative to invasive therapy without increase in mortality., (© Georg Thieme Verlag KG Stuttgart · New York.)

Aims: Transcatheter aortic valve implantation (TAVI) has emerged as a treatment of aortic stenosis in patients at high surgical risk. However, risk stratification in this elderly population is challenging, as patients at extreme risk might not benefit from TAVI. While several clinical criteria have been proposed for estimating the outcome, prediction of individual risk remains difficult. Therefore, our aim was to assess the prognostic value of the biomarker growth differentiation factor 15 (GDF15)., Methods and Results: Over a 2.9-year period, we prospectively enrolled 217 patients undergoing TAVI. Clinical parameters, risk scores, and biomarkers (NT-proBNP and GDF15) were measured at baseline. The primary endpoint was survival time; prognostic factors were analysed by Cox regression analysis. Mean age of study participants was 81.8 ± 6.0 years. Median Logistic EuroSCORE was 20.1 (Q1-Q3 13.6-32.6). Thirty-day mortality was 6.9%; 30.4% of the patients died during follow-up [median 349 days (Q1-Q3 106-660)]. Median pre-procedural GDF15 values were 2256 pg/mL (1585-3082). High GDF15 levels were associated with numerous factors that could contribute to poor outcome. Analyses comparing the upper quartile with the lower three quartiles for biomarker levels revealed a hazard ratio (HR) of increased GDF15 for adverse outcome of 2.4 [95% confidence interval (CI) 1.5-3.9, P < 0.001]. Of note, in multiple analyses, elevated GDF15 levels were superior to NT-proBNP for predicting negative outcome (adjusted HR of GDF15 1.97, 95% CI 1.2-3.3; P = 0.009)., Conclusion: Elevated GDF15 levels were superior to NT-proBNP for TAVI risk stratification and provided additional prognostic information. Thus, patient selection for TAVI may benefit from measurement of GDF15., (© 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.)

We aimed to analyze benefits and risks of aliskiren treatment in older adults (⩾ 65 years) in clinical practice. Patients (n = 14,986) were assigned to either aliskiren (ALIS), an angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker (ACEi/ARB), or an agent not blocking the renin-angiotensin system (non-RAS). Older adults (n = 7396) had a longer history of hypertension (8.7 vs 4.7 years; P < 0.0001), lower mean diastolic blood pressure (DBP; 87.7 ± 11.0 vs 92.1 ± 11.0 mm Hg) and more renal (12.0 vs 5.6%; P < 0.0001) or cardiovascular disease (44.0 vs 18.9%; P < 0.0001); 4548 received aliskiren (68.8%), 1215 ACEi/ARBs (18.4%) and 850 non-RAS treatments (12.9%). Office BP at 1 year was reduced by 18.4 ± 21.5/7.2 ± 12.0 mm Hg. BP reductions were greater (19.5 ± 21.7/7.6 ± 12.1 mm Hg) in the aliskiren group than in the ACEi/ARB (15.6 ± 20.9/6.4 ± 11.9) and non-RAS groups (16.1 ± 20.7/6.5 ± 11.7 mm Hg), respectively (P<0.0001 for systolic BP (SBP) and <0.01 for DBP). After multivariable adjustment, differences in SBP reductions were clinically irrelevant and no differences were noted for DBP. Adverse effects were higher in older adults with no differences between treatment groups. In conclusion, the present analysis of a large, unselected cohort of patients in clinical practice from the 3A study, offers real-life evidence of the effectiveness and safety of aliskiren for the treatment of hypertension in older adults.

Background: Compared with surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI) is associated with a higher risk of developing a new conduction disorder that necessitates permanent pacemaker implantation (PM). The most frequently observed conduction disorder is left bundle branch block (LBBB), which impairs left ventricular function., Objectives: The primary objective of this study was to assess the incidence and prognostic significance of persistent new-onset LBBB following TAVI. Factors predictive of persistent new-onset LBBB were also explored., Methods: This study included a total of 793 patients who underwent TAVI between May 2008 and April 2012. Patients were divided into two groups: those with persistent new-onset LBBB and those without persistent new-onset LBBB. Follow-up was conducted within 1-year of TAVI., Results: Persistent new-onset LBBB was observed in 31.1 % (n = 197) out of 634 eligible patients. At 30 days and 1-year post-TAVI, the all-cause mortality rate was higher in patients with persistent new-onset LBBB (6.1 %, n = 12 and 20.8 %, n = 41, respectively) than in patients without new-onset LBBB (3.3 %, n = 10 and 13.0 %, n = 57, respectively; p = 0.014 and p = 0.010 for the two time points). Multivariate regression analyses revealed, that persistent new-onset LBBB was an independent predictor of all-cause mortality at 1 year (HR 1.84, 95 %CI 1.35-2.02). PM implantation was observed slightly more frequently in patients with persistent new-onset LBBB (14.2 %) than in those without (9.4 %; HR 1.60, 95 %CI 0.96-2.67). Risk factors for pacemaker (PM) were baseline RBBB (HR 6.23, 95 %CI 3.76-10.33), chronic atrial fibrillation (HR 1.75, 95 %CI 1.10-2.56) and the Medtronic CoreValve implantation (HR 2.40, 95 %CI 1.55-3.75). At 1-year follow-up, the mean survival of patients with PM (81.2 %) was slightly lower, but not significantly different from that of patients without PM (85.0 %; p = 0.377). Upon multivariable logistic binary regression analysis Medtronic CoreValve was associated with an increase rate of persistent new-onset LBBB (HR 2.52, 95 %CI 1.67-3.80) and PM implantation. Mortality during 1 year of follow-up, however, was neither increased in the total population (p = 0.232), nor in a subgroup of those with LBBB in a comparison of Medtronic CoreValve and Edwards SAPIEN., Conclusion: This study demonstrated that persistent new-onset LBBB was associated with increased mortality in patients undergoing TAVI. Compared with the Edwards SAPIEN valve, implantation of the Medtronic CoreValve resulted in a higher rate of both persistent new-onset LBBB and PM but not death.

Aims: This study was designed to evaluate safety and effectiveness of the vascular closure device Exoseal (Cordis) for hemostatic control following cardiac catheterization in a real-life clinical setting., Methods and Results: This prospective, single-center study enrolled n = 2,031 consecutive patients who underwent coronary angiography via the femoral artery ± PCI (n = 801). Patients were excluded if they had radial access, percutaneous repair of structural heart disease, or if they had severe peripheral artery disease. If clinical abnormalities were discovered at the access site, color Doppler ultrasound was performed. The composite primary endpoint was defined as bleeding/vascular complications and device failure, and it was experienced by 5.4 % (n = 110) of patients. The most frequent complications were pseudoaneurysm (2.9 %, n = 58) and access-site hematoma >6 cm (1.8 %, n = 37). The overall device failure rate was 0.7 % (n = 14). Multiple logistic regression analysis demonstrated that the strongest independent predictors of bleeding/vascular complications and/or device failure were procedure duration (OR 2.1, CI 1.4-3.2), PCI (OR 2.7, CI 1.7-4.2), GP IIb/IIIa inhibitors (OR 2.9, CI 1.5-5.7), and age (OR 2.2, CI 1.4-3.5)., Conclusions: These results indicate that Exoseal was safe in a broad collective of patients. However, lengthy procedures, PCIs, the use of GP IIb/IIIa inhibitors, and elderly patients require special attention.

Transition from the hospital into the outpatient setting is a critical event for the appropriate provision of VTE prophylaxis. Data for this transition for the situation in Germany is scant. This was a retrospective, observational study in patients receiving in-hospital thromboprophylaxis and discharged with or without a recommendation to continue. Patient with previous thromboembolism were excluded. A total of 3,211 patients were identified by 518 physicians of which 2,853 had all data available for the present analysis; mean patient's age was 57.4 ± 17.5 (SD) years, 48.2% were male and bodyweight was 79.8 ± 16.1 kg. During hospitalization 95.5% of surgical and 84.0% of medical patients received any thromboprophylaxis, the mean hospital duration being 12.7 ± 20.3 days. Surgical patients had high, medium and low risk in 53.8, 37.1 and 9.1%, respectively. Medical patients had high, medium and low risk in 78.8, 19.8 and 1.4%. A hospital recommendation to continue thromboprophylaxis was given to 84.6% (95% CI 83.1-85.9%) of surgical and 64.9% (95% CI 59.1-70.6%) of medical patients and implemented in 96.6 and 94.3%, respectively. On the other hand, in patients without a respective hospital recommendation (15.4% of surgical and 35.1% of medical patients), thromboprophylaxis was continued in 65.3% of surgical and 73.1% of medical patients because of high risk. Our data illustrate acceptable rates of prophylaxis in surgical and medical patients in Germany. As the results show, it is essential that not only hospital physicians are aware of the actual risk at discharge, but office based physicians assess thromboembolic risk.

Background: Clinical trials indicate that the use of fixed-dose combinations (FDCs) is associated with a higher level of treatment adherence and prolonged blood pressure (BP) control. The aim of this study was to document the safety and effectiveness of the FDC olmesartan/amlodipine/hydrochlorothiazide in patients with essential hypertension in clinical practice., Methods: This multicenter, prospective, 24-week, noninterventional study enrolled 5,831 patients from primary care offices in Germany and Austria. Inclusion criteria were a diagnosis of essential hypertension and newly initiated treatment with the FDC., Results: The mean age of patients was 63.5 years, almost 50% of patients had a time since diagnosis of essential hypertension of over 5 years, and approximately 70% of patients had at least one cardiovascular risk factor, including 29.4% of patients with diabetes mellitus. Following approximately 24 weeks of treatment, the mean reduction in systolic/diastolic BP was 29.0/14.0 mmHg, a BP response was observed by 94.2% of patients, and a target BP of <140/90 mmHg was attained in 67.5% of patients. At least one adverse drug reaction (ADR) was experienced by 1.2% of patients, with the most common being peripheral edema. Subanalyses demonstrated that the following factors did not have a significant influence on the ADR rate: age (<65 years versus ≥65 years), diabetes mellitus (no/yes), cardiovascular risk (low/high), and concomitant medication (no/yes)., Conclusion: This study demonstrates that in clinical practice, treatment with the three-drug combination as an FDC tablet resulted in a very high proportion of patients with a BP response and control, accompanied by a very low rate of ADRs.

Background: In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required., Methods/design: Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning., Discussion: Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis., Trial Registration: ClinicalTrials.gov Identifier: NCT02127580.

Background: Aortic rupture of the device landing zone is a rare complication of transcatheter aortic valve implantation (TAVI) and it is associated with significant mortality., Methods: This study reports on the experience of a single-center in a case series of more than 1,000 implants. We explored patient and procedural characteristics aiming at identifying variables that increase the risk for aortic root rupture., Results: Among a total of 1,000 TAVI procedures, six patients (0.6 %) had a rupture of the device landing zone. Five of these patients received the balloon-expandable Edwards SAPIEN valve (5/813; 0.62 %) of which four had a supraannular and one a subannular rupture. One patient received the self-expanding Medtronic CoreValve (1/199; 0.5 %; p = n.s. vs. SAPIEN) and had an annular rupture. Factors that were associated with aortic rupture were: (1) the relative size of the valve compared with the aortic annulus and its geometric form; (2) the need for post-dilation of the new valve because of paravalvular leakage; and (3) the location and severity of calcification. We determined, to avoid aortic rupture, caution may be necessary in the presence of the following conditions: (1) flat sinuses of Valsalva and severe calcifications of either the body or the free edge of the aortic cusps (supraannular rupture); (2) an ellipsoid annulus and bulky calcifications on either the base of the cusps or the rim of the annulus (annular rupture); and (3) a narrow left-ventricular outflow tract (LVOT) and bulky calcification of the LVOT (subannular rupture). After considering these precautions, we observed no case of aortic root rupture in the following 600 cases., Conclusion: The data indicate that to reduce the frequency of aortic rupture, a careful pre-procedural planning appears essential to avoid this serious and potentially deleterious complication.

Background: In Germany, care for patients with chronic heart failure (HF) is provided by hospital-based cardiologists (HBC), office-based cardiologists (OBC) and general practitioners (GP). We aimed to compare patient characteristics, diagnostic approaches and therapeutic decisions., Methods: Multi-centre, cross-sectional, observational survey at 48 physicians. Patients (n = 384) were required to have previously diagnosed HF and NYHA class ≥ II and/or a left ventricular ejection fraction of <50 %. A total of 384 patients were included at 5 HBCs, 26 OBCs and 18 GPs., Results: A mean of 18.8 % of all patients at HBCs practices had heart failure, compared to a smaller proportion of 13.9 and 6.7 % at OBCs and GPs, respectively. Echo facility was available for all HBCs and OBCs, but for 16.7 % of GPs (p < 0.0001 for trend). Patients at HBCs had a higher NYHA class (65.6 % had class III/IV; p < 0.0001) compared to 36.8 % at OBCs and 39.3 % at GPs. Usage of three guideline-recommended pharmaceutical treatments was more than 80 %: diuretics (83.1 %), renin-angiotensin system blocking agents (91.4 %) and betablockers (90.1 %) with no differences between physician groups. Mineralocorticoid receptor antagonists (MRAs, overall 47.7 %) were more frequently prescribed by OBCs (54.7 %; p = 0.0007 for trend) than HBCs (43.8 %) and GPs (31.0 %). Ivabradin was not frequently used (11.0 % at OBCs, 4.9 % at HBCs and 0 % at GPs; p = 0.0163 for trend). The proportion of patients with CRT (8.6 %), ICD (23.5 %) and CABG (23.1 %) was not statistically different between groups., Conclusion: REFLECT-HF demonstrates that there are some differences in evidence-based treatment decisions between the three main health services (HBC, OBC and GP) providing care for patients with HF in Germany. Advocating adherence to guideline recommendations and earlier adoption of these evidence-based treatments across all levels of care might further improve patient care.

Atrial fibrillation is the most common cardiac arrhythmia. It is an independent risk factor for cardiovascular complications and stroke. The treatment options for atrial fibrillation have changed significantly in recent years by new drugs and ablative procedures. It is based on the principal strategies of anticoagulation, rhythm and rate control. Goal is to reduce symptoms and subsequent events. Although the costs of about 700 to pound 800 per patient per year are rather high, new treatment options might be associated with a reduction in event rates and an increase in quality adjusted life years (QALYs). The aim of this review is to give a practical overview of the epidemiology, diagnosis, treatment and costs to pharmacists who have a key role in the implementation of pharmacotherapy of atrial fibrillation.

Background: Due to the variety of affected organ systems, necessitating a multidisciplinary and interconnected approach in deciding on individual diagnostic and therapeutic strategies, a structured documentation of data for patients suffering from diabetes mellitus is steadily gaining importance. Towards this purpose, multiple quality initiatives (e. g. SWEET, QS-DPV, EUBIROD etc.) as well as several software systems (e. g. [DPV2] DIAMAX, DPV, EMIL, Qmax etc.) have been developed to capture patient-related data. This is further complicated by the necessity to exchange data with a large variety of doctor's office administration systems., Methods: To address this complex of issues, DiabetesDE in cooperation with several societies, doctor's associations and prospective end users launched a national register platform. DIVE (Diabetes Care Evaluation) is aimed at establishing a national diabetes register to centrally capture data from diabetes patients being treated by diabetology specialists in Germany, thus making them available for quality assurance and health services research., Results: Since September 2011, 142 so far participating doctors have documented data for 84,774 patients. Compared to patients treated by general practitioners, persons under specialist care show a more advanced clinical picture with substantial co-morbidity., Conclusion: DIVE provides a national platform which will address essential fields of activity with regard to the development of a national diabetes strategy--epidemiology, diabetes registry, health care research, quality assurance--based on usual office administration systems, thus contributing to the improvement of care and treatment for patients suffering from diabetes., (© Georg Thieme Verlag KG Stuttgart · New York.)

Aims: There are concerns that biosimilar erythropoiesis-stimulating agents (ESAs) are less effective than the originator ESAs. The objective of our study was to investigate differences between originator and biosimilar ESA utilisation based on defined daily doses (DDD), doses upon switching, differences between short- and long-acting ESAs and prescribed daily doses (PDD) of either ESA in ambulatory patients with renal anaemia undergoing chronic maintenance haemodialysis [chronic kidney disease (CKD) stage 5]., Methods: Patients with CKD stage 5 and specific pharmacotherapy with ESAs for at least six 3-month periods (accounting quarters) were selected from a population-based database of accounting information of Bavarian physicians and pharmacy claims data (January 2008 to December 2010). The DDD was used to determine mean ESA consumption. Descriptive statistics were used to describe the results., Results: In our study, 6,177 CKD stage 5 patients received ESAs for ≥6 accounting quarters, of whom 64.4 % received originator ESAs, 21.1 % received biosimilars and 14.6 % received any sequence originator and biosimilar (total of 35.7 % any biosimilar). Patients receiving either originator short-acting ESAs, long-acting darbepoetin-alfa or M-PEG epoetin-beta had a median DDD consumption of 0.77, 0.81 and 0.90, respectively. Patients receiving a biosimilar short-acting ESA had a median DDD consumption of 0.82. Doses were not increased when the therapy was switched from the originator to the biosimilar ESA. These results were confirmed in 1,886 patients receiving a continuous prescription over 12 accounting quarters, with patients receiving short-acting originator ESAs, long-acting darbepoetin-alfa and biosimilar ESAs having a median daily DDD consumption of 0.80, 0.86 and 0.81, respectively., Conclusions: We conclude that, based on a population based analysis, ESA consumption of patients on chronic haemodialysis is similar for biosimilar and originator ESAs.

Background: Atrial fibrillation (AF) is increasingly prevalent in elderly patients and adversely affects clinical outcomes after coronary artery bypass grafting, non-cardiac surgery or myocardial infarction. Aim of the present analysis was to investigate the prognostic impact of AF in patients undergoing drug eluting stent (DES) implantation during a 1-year follow-up., Patients and Methods: 5,772 consecutive patients undergoing percutaneous coronary intervention were enrolled into the German Drug Eluting Stent Registry (DES.DE) and were followed for 12 months. Of these 455 had AF and 5,317 in sinus rhythm served as controls. Univariate and multivariate logistic regression analyses were used to determine the risk of major adverse cardiac and cerebrovascular events (MACCE) and bleeding complications., Results: Patients with AF were older (71.3 ± 7.6 vs. 64.7 ± 10.5 years) and had a higher prevalence of diabetes, hypertension, renal insufficiency as well as more prior bypass surgery, stroke and peripheral arterial disease. Cardiogenic shock (2.9 vs. 1.4 %; p < 0.05), left ventricular ejection fraction ≤40 % (21.0 vs. 11.4 %; p < 0.0001) and triple vessel disease (44.4 vs. 37.9 %; p < 0.01) were more frequent in patients with AF than in controls. MACCE (OR 2.08, 95 % CI 1.56-2.77), total mortality (OR 3.27, 95 % CI 2.32-4.62) and non-fatal stroke (OR 2.03, 95 % CI 1.03-4.00) as well as bleeding complications (OR 1.88, 95 % CI 1.13-3.12) during the 1-year follow-up were more frequent in patients with AF (univariate analysis). In multivariate analyses adjusting for covariates determined to be relevant at baseline, the risk for total mortality remained elevated (OR 1.63, 95 % CI 1.05-2.52)., Conclusions: AF is an important predictor of long-term mortality in patients undergoing DES implantation.

Background: The aim of this study was to compare the efficacy and tolerability of enoxaparin for preventing thromboembolism after surgery in the out-patient and in-hospital settings., Materials and Methods: A total of 2,005 out-patient and 1,360 hospitalized patients were included in the study. Prophylaxis was carried out with 20 or 40 mg enoxaparin and follow-up examination after 4-6 weeks., Results: Out-patients were younger (mean 48.4 vs. 58.5 years, p<0.01), had less cardiovascular comorbid diseases (7.1 vs. 20.8%, p<0.01) and underwent less complex interventions (arthroscopy 33.6 vs. 7.5%, p<0.01). Out-patients also received 20 instead of 40 mg enoxaparin more frequently (60.7 vs. 38.3%, p<0.01). The mean duration of thromboprophylaxis was reduced (12.6 vs. 15.3 days). For patients treated with 20 and 40 mg minor bleeding was observed in 1.8 and 3.4%, respectively (4.7 with 20 mg and 4.5% with 40 mg in hospital), major bleeding was 0.1% for both doses in out-patients and 0.0% with 20 mg and 0.3% with 40 mg in-hospital. Deep vein thrombosis (DVT) occurred in 0.4% of out-patients receiving 20 mg enoxaparin and 0.6% with 40 mg (0.0% with 20 mg and 0.9% with 40 mg in-hospital). There were no cases of pulmonary embolism (PE) in out-patients but PE was observed in 0.2% and 0.5% with 20 mg and 40 mg in-hospital patients, respectively., Conclusions: Thromboprophylaxis with enoxaparin is well tolerated under clinical conditions as well as under out-patient treatment and severe bleeding complications are rare.